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BOTOX® (onabotulinumtoxinA) Important Information

IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING

WARNING: DISTANT SPREAD OF TOXIN EFFECT

Postmarketing reports indicate that the effects of BOTOX® and all botulinum toxin
products may spread from the area of injection to produce symptoms consistent with botulinum toxin
effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia,
dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to
weeks after injection. Swallowing and breathing difficulties can be life threatening, and there have been reports of death.
The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can also occur in adults treated
for spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to these symptoms.
In unapproved uses, including spasticity in children, and in approved indications, cases of spread of effect have been reported at doses
comparable to those used to treat cervical dystonia and spasticity and at lower doses.

Indications
Bladder Dysfunction:

Overactive Bladder
BOTOX® for injection is indicated for the treatment of overactive bladder with
symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate
response to or are intolerant of an anticholinergic medication.

Detrusor Overactivity Associated With a Neurologic Condition
BOTOX® is indicated for the treatment of urinary incontinence due to
detrusor overactivity associated with a neurologic condition (eg, SCI, MS) in adults who
have an inadequate response to or are intolerant of an anticholinergic medication.

Chronic Migraine

BOTOX® is indicated for the prophylaxis of headaches in adult patients with
chronic migraine (≥ 15 days per month with headache lasting 4 hours a day or longer).

Important Limitations

Safety and effectiveness have not been established for the prophylaxis of episodic
migraine (14 headache days or fewer per month) in 7 placebo-controlled studies.

Important Limitations

Safety and effectiveness of BOTOX® have not been established for the treatment of other upper or lower limb muscle groups. Safety
and effectiveness of BOTOX® have not been established for the treatment of spasticity in pediatric patients under age 18 years. BOTOX®
has not been shown to improve upper extremity functional abilities, or range of motion at a joint affected by a fixed contracture. Treatment with BOTOX®
is not intended to substitute for usual standard of care rehabilitation regimens.

Cervical Dystonia

BOTOX® is indicated for the treatment of adults with cervical dystonia to reduce the
severity of abnormal head position and neck pain associated with cervical dystonia.

Blepharospasm and Strabismus

BOTOX® is indicated for the treatment of strabismus and blepharospasm associated with dystonia, including benign essential
blepharospasm or VII nerve disorders in patients 12 years of age and above.

Primary Axillary Hyperhidrosis

BOTOX® is indicated for the treatment of severe primary axillary hyperhidrosis that is
inadequately managed with topical agents.

Important Limitations

The safety and effectiveness of BOTOX® for hyperhidrosis in other body areas have not
been established. Weakness of hand muscles and blepharoptosis may occur in patients
who receive BOTOX® for palmar hyperhidrosis and facial hyperhidrosis, respectively.
Patients should be evaluated for potential causes of secondary hyperhidrosis (eg,
hyperthyroidism) to avoid symptomatic treatment of hyperhidrosis without the diagnosis
and/or treatment of the underlying disease.

Safety and effectiveness of BOTOX® have not been established for the treatment of
axillary hyperhidrosis in pediatric patients under age 18.

IMPORTANT SAFETY INFORMATION (continued)
CONTRAINDICATIONS

BOTOX® is contraindicated in the presence of infection at the proposed injection site(s)
and in individuals with known hypersensitivity to any botulinum toxin preparation or to
any of the components in the formulation.

Intradetrusor injection of BOTOX® is contraindicated in patients with overactive bladder
or detrusor overactivity associated with a neurologic condition who have a urinary tract
infection (UTI). Intradetrusor injection of BOTOX® is also contraindicated in patients
with urinary retention and in patients with post-void residual (PVR) urine volume > 200
mL, who are not routinely performing clean intermittent self-catheterization (CIC).

WARNINGS AND PRECAUTIONS

Lack of Interchangeability Between Botulinum Toxin Products
The potency Units of BOTOX® are specific to the preparation and assay method
utilized. They are not interchangeable with other preparations of botulinum toxin
products and, therefore, Units of biological activity of BOTOX® cannot be compared to nor
converted into Units of any other botulinum toxin products assessed with any other specific assay method.

Spread of Toxin Effect
See Boxed Warning.

No definitive serious adverse event reports of distant spread of toxin effect associated with BOTOX® for blepharospasm
at the recommended dose (30 Units and below), severe primary axillary hyperhidrosis at the recommended dose (100 Units), strabismus,
or for chronic migraine at the labeled doses have been reported.

Serious Adverse Reactions With Unapproved Use
Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with
some adverse reactions associated with fatal outcomes, have been reported in patients who received BOTOX®
injections for unapproved uses. In these cases, the adverse reactions were not necessarily related to distant
spread of toxin, but may have resulted from the administration of BOTOX® to the site of injection and/or
adjacent structures. In several of the cases, patients had pre-existing dysphagia or other significant disabilities.
There is insufficient information to identify factors associated with an increased risk for adverse reactions
associated with the unapproved uses of BOTOX®. The safety and effectiveness of BOTOX® for unapproved uses
have not been established.

Hypersensitivity Reactions
Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum sickness,
urticaria, soft-tissue edema, and dyspnea. If such a reaction occurs, further injection of BOTOX® should be discontinued
and appropriate medical therapy immediately instituted. One fatal case of anaphylaxis has been reported in which lidocaine
was used as the diluent, and consequently the causal agent cannot be reliably determined.

Dysphagia and Breathing Difficulties
Treatment with BOTOX® and other botulinum toxin products can result in swallowing or breathing difficulties.
Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications.
In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in
breathing or oropharyngeal muscles that control swallowing or breathing (see Boxed Warning).

Pulmonary Effects of BOTOX® in Patients With Compromised Respiratory Status Treated for Spasticity or for Detrusor Overactivity Associated With a Neurologic Condition
Patients with compromised respiratory status treated with BOTOX® for
spasticity or detrusor overactivity associated with a neurologic condition should be
monitored closely.

Corneal Exposure and Ulceration in Patients Treated With BOTOX® for Blepharospasm
Reduced blinking from BOTOX® injection of the orbicularis muscle can lead to corneal
exposure, persistent epithelial defect, and corneal ulceration, especially in patients with
VII nerve disorders.

Retrobulbar Hemorrhages in Patients Treated With BOTOX® for Strabismus
During the administration of BOTOX® for the treatment of strabismus, retrobulbar
hemorrhages sufficient to compromise retinal circulation have occurred. It is
recommended that appropriate instruments to decompress the orbit be accessible.

Bronchitis and Upper Respiratory Tract Infections in Patients Treated for Spasticity
Bronchitis was reported more frequently as an adverse reaction in patients treated for
upper limb spasticity with BOTOX® (3% at 251 Units to 360 Units total dose) compared to
placebo (1%). In patients with reduced lung function treated for upper limb spasticity,
upper respiratory tract infections were also reported more frequently as adverse reactions in patients
treated with BOTOX® (11% at 360 Units total dose; 8% at 240 Units total dose) compared to placebo (6%).
In adult patients treated for lower limb spasticity, upper respiratory tract infections were reported more frequently
as an adverse event in patients treated with BOTOX® (2% at 300 Units to 400 Units total dose) compared to placebo (1%).

Autonomic Dysreflexia in Patients Treated for Detrusor Overactivity Associated With a Neurologic Condition
Autonomic dysreflexia associated with intradetrusor injections of BOTOX® could occur
in patients treated for detrusor overactivity associated with a neurologic condition and
may require prompt medical therapy. In clinical trials, the incidence of autonomic
dysreflexia was greater in patients treated with BOTOX® 200 Units compared with
placebo (1.5% versus 0.4%, respectively).

Urinary Tract Infections in Patients With Overactive Bladder
BOTOX® increases the incidence of urinary tract infection. Clinical trials for overactive
bladder excluded patients with more than 2 UTIs in the past 6 months and those taking
antibiotics chronically due to recurrent UTIs. Use of BOTOX® for the treatment of
overactive bladder in such patients and in patients with multiple recurrent UTIs during
treatment should only be considered when the benefit is likely to outweigh the potential
risk.

Urinary Retention in Patients Treated for Bladder Dysfunction
Due to the risk of urinary retention, treat only patients who are willing and able to initiate
catheterization post-treatment, if required, for urinary retention.

In patients who are not catheterizing, post-void residual (PVR) urine volume should be
assessed within 2 weeks post-treatment and periodically as medically appropriate up to
12 weeks, particularly in patients with multiple sclerosis or diabetes mellitus. Depending
on patient symptoms, institute catheterization if PVR urine volume exceeds 200 mL and
continue until PVR falls below 200 mL. Instruct patients to contact their physician if they
experience difficulty in voiding as catheterization may be required.

Overactive Bladder
In clinical trials, 6.5% of patients (36/552) initiated clean intermittent catheterization for
urinary retention following treatment with BOTOX® 100 Units as compared to 0.4% of
patients (2/542) treated with placebo. The median duration of catheterization for patients treated with BOTOX®
100 Units was 63 days (minimum 1 day to maximum 214 days) as compared to a median duration 11 days (minimum 3 days to maximum
18 days) for patients receiving placebo.

Patients with diabetes mellitus treated with BOTOX® were more likely to develop urinary
retention than non-diabetics. In clinical trials, 12.3% of patients (10/81) with diabetes
developed urinary retention following treatment with BOTOX® 100 Units vs 0% patients
(0/69) treated with placebo. In patients without diabetes, 6.3% of patients (33/526)
developed urinary retention following treatment with BOTOX® 100 Units vs 0.6% of
patients (3/516) treated with placebo.

Detrusor Overactivity Associated With a Neurologic Condition
In clinical trials, 30.6% of patients (33/108) who were not using clean intermittent
catheterization (CIC) prior to injection, required catheterization for urinary retention
following treatment with BOTOX® 200 Units as compared to 6.7% of patients (7/104)
treated with placebo. The median duration of post-injection catheterization for these
patients treated with BOTOX® 200 Units (n = 33) was 289 days (minimum 1 day to
maximum 530 days) as compared to a median duration 358 days (minimum 2 days to
maximum 379 days) for patients receiving placebo (n = 7).

Among patients not using CIC at baseline, those with MS were more likely to require
CIC post-injection than those with SCI.

Human Albumin and Transmission of Viral Diseases
This product contains albumin, a derivative of human blood. Based on effective donor
screening and product manufacturing processes, it carries an extremely remote risk for
transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob
disease (CJD) is also considered extremely remote. No cases of transmission of viral
diseases or CJD have ever been reported for albumin.

ADVERSE REACTIONS

The following adverse reactions to BOTOX® for injection are discussed in greater detail in the following sections:
Spread of Toxin Effect (see Boxed Warning); Serious Adverse Reactions With Unapproved Use (see Warnings and Precautions);
Hypersensitivity Reactions (see Contraindications and Warnings and Precautions); Increased Risk of Clinically Significant
Effects With Pre-Existing Neuromuscular Disorders (see Warnings and Precautions); Dysphagia and Breathing Difficulties
(see Warnings and Precautions); Pulmonary Effects of BOTOX® in Patients With Compromised Respiratory Status
Treated for Spasticity or for Detrusor Overactivity Associated With a Neurologic Condition (see Warnings and Precautions);
Corneal Exposure and Ulceration in Patients Treated for Blepharospasm (see Warnings and Precautions); Retrobulbar Hemorrhages
in Patients Treated for Strabismus (see Warnings and Precautions); Bronchitis and Upper Respiratory Tract Infections in Patients
Treated for Spasticity (see Warnings and Precautions); Autonomic Dysreflexia in Patients Treated for Detrusor Overactivity
Associated With a Neurologic Condition (see Warnings and Precautions); Urinary Tract Infections in Patients With Overactive Bladder
(see Warnings and Precautions); and Urinary Retention in Patients Treated for Bladder Dysfunction (see Warnings and Precautions).

Severe worsening of migraine requiring hospitalization occurred in approximately 1% of BOTOX® treated patients in study 1 and study 2,
usually within the first week after treatment, compared with 0.3% of placebo-treated patients.

Post Marketing Experience
There have been spontaneous reports of death, sometimes associated with dysphagia,
pneumonia, and/or other significant debility or anaphylaxis, after treatment with
botulinum toxin. There have also been reports of adverse events involving the
cardiovascular system, including arrhythmia and myocardial infarction, some with fatal
outcomes. Some of these patients had risk factors including cardiovascular disease. The exact
relationship of these events to the botulinum toxin injection has not been
established.

DRUG INTERACTIONS

Co-administration of BOTOX® and aminoglycosides or other agents interfering with neuromuscular transmission
(eg, curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated.
Use of anticholinergic drugs after administration of BOTOX® may potentiate systemic anticholinergic effects. The
effect of administering different botulinum neurotoxin products at the same time or within several months of each
other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin
prior to the resolution of the effects of a previously administered botulinum toxin. Excessive weakness may also be
exaggerated by administration of a muscle relaxant before or after administration of BOTOX®.

Important Limitations
Safety and effectiveness of BOTOX® have not been established for the treatment of other upper or lower limb muscle groups. Safety
and effectiveness of BOTOX® have not been established for the treatment of spasticity in pediatric patients under age 18 years. BOTOX®
has not been shown to improve upper extremity functional abilities, or range of motion at a joint affected by a fixed contracture. Treatment with BOTOX®
is not intended to substitute for usual standard of care rehabilitation regimens.